MAUDE Adverse Event Report: ABBOTT MEDICAL ENSITE¿ X SOFTWARE V3.1; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	ENSITE-SW-3.1
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a supraventricular tachycardia voxel procedure, display issues resulted in a procedural delay.The map shifted noticeably without patient movement.The case was restarted twice and remapped, and the metal baseline was reset.The procedure was completed successfully with no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information: b5, a2, a3a, a4, g3, h2.
Event or Problem Description
This report includes patient information.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6.The case study and log files were provided for review.The provided files were reviewed, and it was determined that the root cause was manual user reset of the prs-p after they were flagged for movement.Following reset of the prs-p, the expected behavior is that both voxels and magnetic positional reference are reset.No software anomaly was found.

• Brand Name: ENSITE¿ X SOFTWARE V3.1
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer (Section G): ABBOTT MEDICAL; one st. jude medical drive; st. paul MN 55117
• Manufacturer Contact: wendy mccarty ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22211849
• Report Number: 2184149-2025-00117
• Device Sequence Number: 8748737
• Product Code: DQK
• UDI-Device Identifier: 05415067049704
• UDI-Public: 05415067049704
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K242016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENSITE-SW-3.1
• Device Catalogue Number: ENSITE-SW-3.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2025
• Supplement Date Received by Manufacturer: 07/01/2025; 10/28/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/23/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 114 KG